Status:
COMPLETED
Vitamin D and Coronary Calcification Study
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Abbott
Conditions:
Chronic Kidney Disease
Vitamin D Deficiency
Eligibility:
All Genders
25+ years
Phase:
PHASE4
Brief Summary
Patients with chronic kidney disease (CKD) have a higher mortality rate than the general population, with cardiovascular disease (CVD) accounting for approximately 50% of deaths. Vascular calcificatio...
Detailed Description
Coronary artery calcification (CAC) is a risk marker for CVD and mortality. In animal models, calcitriol significantly increased the serum calcium-phosphate product and aortic calcium content, while p...
Eligibility Criteria
Inclusion
- CKD stages 3 or 4 (estimated glomerular filtration rate (eGFR) between 15 and 59)
- Diagnosis of secondary hyperparathyroidism, which is defined as:
- Elevated intact PTH (iPTH) as per KDIGO guidelines:
- CKD stage 3 (eGFR 30-59) or CKD stage 4 (eGFR 15-29) with iPTH \> Upper Limit of Normal for lab (6.8 pmol/L)
- Presence of Coronary Artery Calcium (CAC \> 0)
- Subject will be able to complete the study, to the best of his/her knowledge
Exclusion
- iPTH \>1500 pg/ml
- Current or previous use of bisphosphonates
- History of parathyroidectomy or anticipated parathyroidectomy
- History of cinacalcet use
- History of a solid organ transplant or scheduled date for transplant surgery
- History of coronary revascularization (coronary artery bypass surgery or percutaneous intervention)
- History of coronary artifact (e.g. pacemaker, intracardiac defibrillator, artificial valve or biventricular leads)
- Active atrial fibrillation
- Weight greater than 300 pounds (due to limitations of equipment)
- HIV positive
- Current pregnancy (although pregnancy is very rare in the CKD population)
- Life expectancy less than two years as judged by primary physician
- Institutionalized patients (nursing home or prisoners)
- Language barrier or mental incapacity to consent
- Inability to swallow tablets or current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00752102
Start Date
September 1 2008
End Date
October 1 2013
Last Update
December 8 2017
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19107